Marco joined the ROCHEM team in April, 2008. With over 15 years of experience in the Pharmaceutical industry, his early career was spent at Bayer Corporation where he led a team of scientists in various areas of QA/QC. Most recently, Marco spent 6 years with Chemwerth Inc. U.S.A. where he was the Sr. V.P. of Global Regulatory Affairs and Compliance. He has extensive experience working with many of China's leading pharmaceutical companies in all areas of Regulatory/Compliance & Quality Control. Marco is committed to ensuring that all of ROCHEM’s suppliers maintain the highest level of compliance and continue to provide products of the highest quality. Marco has performed hundreds of supplier GMP audits globally and is recognized as an industry leader and a global expert in his field for filing regulatory submissions in both North America and Europe.
James received his M.Sc in Pharmaceutical Technology at King's College London after graduation from the Medical Centre of Shanghai Fudan University. James has been working in the Pharmaceutical industry for more than seven years in various areas of Compliance and Quality management. James has worked for such companies as The Shanghai Pharmaceutical Group, Chemwerth Inc (Shanghai) and Kunshan Oriental Pharmaceutical Co, Ltd. Prior to joining Rochem, he was the VP of Quality at Kunshan Oriental Pharmaceutical Co., Ltd. James has extensive experience in performing cGMP audits and working with FDA/EDQM inspection teams as well as educating and leading Chinese Manufacturers to achieve and maintain the highest level of cGMP compliance.
Dongming Wei
Senior Manager Regulatory and Compliance
dmwei@rochemintl.com
Dongming joined Rochem after having earned his college degree from Wuhan University and spending nearly a decade with Shandong Xinhua Pharmaceutical. Dongming’s exposure to writing and filing DMFs, along with being involved with US FDA inspections, have prepared him to be a key part of Rochem’s success in preparing and assisting manufacturers to meet US FDA requirements.
Melissa Authelet
Regulatory Affairs Associate
Melissa joined the Rochem Regulatory Affairs department in
March 2010. Since graduating with a Bachelor’s degree in Biology from
Binghamton University, she has worked in pharmaceutical sales support for a
leading OTC Pharmaceutical firm as well as in product development at NBTY, Inc.
Melissa’s experience with customers in both the nutritional and pharmaceutical
industries has enabled her to gain the experience necessary to support the
needs and requirements of Rochem’s customers. Melissa’s knowledge, attention to
detail and sense of urgency will be an invaluable asset to Rochem and our
customers.